Detection System for Syringe Assembly

ABSTRACT

Detection systems for a syringe assembly that provide precision in monitoring the amount of fluid contained within the syringe barrel, detecting motion of the plunger within the syringe barrel, detecting the position of the plunger within the syringe barrel, and/or monitoring the volume received within or delivered by the syringe assembly are disclosed. A detection system of the present disclosure allows a sensor in communication with a portion of a plunger assembly to sense the motion of a plunger rod relative to a syringe barrel and thereby volume received within or delivered by the syringe by reading gradations having an identifier directly as the plunger rod with sensor moves past each respective gradation with identifier.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.17/600,695 filed Apr. 1, 2020, which is the United States national phaseof International Application No. PCT/US2020/026111 filed Apr. 1, 2020,and claims priority to U.S. Provisional Application Ser. No. 62/828,025,filed Apr. 2, 2019, entitled “Detection System for Syringe Assembly”,the entire disclosures of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION 1. Field of the Disclosure

The present disclosure relates generally to a detection system for asyringe assembly. More particularly, the present disclosure relates toan identifier in a first portion of the syringe assembly and a sensor ina second portion of the syringe assembly to detect motion of the syringeassembly and monitor the volume received within or delivered by thesyringe assembly.

2. Description of the Related Art

Syringe assemblies, and in particular hypodermic syringes, are wellknown in the medical field for dispensing fluids, such as medications. Aconventional syringe typically includes a syringe barrel with an openingat one end and a plunger mechanism disposed through the opposite end.The plunger mechanism typically includes a plunger rod extending throughthe barrel, with a plunger head or stopper disposed at the end of theplunger rod within the syringe barrel, and with a finger flange at theother end of the plunger rod extending out of the syringe barrel. Inuse, the plunger rod is retracted through the syringe barrel to aspirateor fill the syringe barrel with a fluid, such as a medication, with theplunger rod extending out from the rear end of the syringe barrel. Fordelivery of the medication to a patient, the opening of the syringebarrel is adapted for fluid communication with a patient, such asthrough a hypodermic needle fitted at the front end of the syringebarrel or through a luer-type fitting extending from the syringe barrelfor attachment with a fluid line of a patient. Upon the user applying aforce to depress the plunger rod and stopper through the syringe barreltowards the front end of the syringe barrel, the contents of the syringeare thereby forced out of the syringe barrel through the opening at thefront end for delivery to the patient. Such an operation is well knownin the medical field, and medical practitioners have become wellaccustomed to the use of such common fluid delivery procedures throughstandard syringes.

A syringe barrel may include markings, such as gradations located on asidewall of the syringe barrel, for providing an indication as to thelevel or amount of fluid contained within an interior chamber of thesyringe barrel. However, there is a need for more precise systems formonitoring the amount of fluid contained within the syringe barrel,detecting motion of the plunger within the syringe barrel, detecting theposition of the plunger within the syringe barrel, and/or monitoring thevolume received within or delivered by the syringe assembly.

SUMMARY OF THE INVENTION

The present disclosure provides detection systems for a syringe assemblythat provide precision in monitoring the amount of fluid containedwithin the syringe barrel, detecting motion of the plunger within thesyringe barrel, detecting the position of the plunger within the syringebarrel, and/or monitoring the volume received within or delivered by thesyringe assembly.

A detection system of the present disclosure allows a sensor incommunication with a portion of a plunger assembly to sense the motionof a plunger rod relative to a syringe barrel and thereby volumereceived within or delivered by the syringe by reading gradations havingan identifier directly as the plunger rod with sensor moves past eachrespective gradation with identifier.

In accordance with an embodiment of the present invention, a syringeassembly includes a syringe barrel having a first end, a second end, anda sidewall extending therebetween and defining an interior; a pluralityof gradations located on a portion of the sidewall, the plurality ofgradations each including an identifier; a plunger assembly having afirst end, a second end, and a plunger stopper portion slidably disposedwithin the interior of the syringe barrel, the plunger stopper portionsized relative to the interior of the syringe barrel to provide sealingengagement with the sidewall of the syringe barrel; and a sensor incommunication with a portion of the plunger assembly, wherein the sensordetects the identifier.

In one configuration, the sensor is positioned within a portion of theplunger assembly. In another configuration, the sensor is mounted on aportion of the plunger assembly. In yet another configuration, thesensor is formed as part of a portion of the plunger assembly. In oneconfiguration, the gradations are located on an inner portion of thesidewall. In another configuration, the syringe assembly includes humanreadable gradations on an outer portion of the sidewall. In yet anotherconfiguration, the gradations are located on an outer portion of thesidewall. In one configuration, the syringe assembly includes humanreadable gradations on an outer portion of the sidewall. In anotherconfiguration, the identifiers are part of the human readablegradations. In yet another configuration, the identifiers aretransparent. In one configuration, the identifier is magnetic. Inanother configuration, the sensor is a magnetic sensor. In yet anotherconfiguration, the identifier is IR ink. In one configuration, thesensor is an optical sensor. In another configuration, the identifier isUV ink.

In accordance with another embodiment of the present invention, asyringe assembly includes a syringe barrel having a first end, a secondend, and a sidewall extending therebetween and defining an interior; aplurality of gradations located on a portion of the sidewall, theplurality of gradations each including an identifier; a plunger rodhaving a first end and a second end; a stopper engaged with the secondend of the plunger rod and slidably disposed within the interior of thesyringe barrel, the stopper sized relative to the interior of thesyringe barrel to provide sealing engagement with the sidewall of thesyringe barrel; and a sensor that detects the identifier.

In one configuration, the sensor is positioned within a portion of theplunger rod. In another configuration, the sensor is mounted on aportion of the plunger rod. In yet another configuration, the sensor isformed as part of a portion of the plunger rod. In one configuration,the sensor is positioned within a portion of the stopper. In anotherconfiguration, the sensor is mounted on a portion of the stopper. In yetanother configuration, the sensor is formed as part of a portion of thestopper. In one configuration, the gradations are located on an innerportion of the sidewall. In another configuration, the syringe assemblyincludes human readable gradations on an outer portion of the sidewall.In yet another configuration, the gradations are located on an outerportion of the sidewall. In one configuration, the syringe assemblyincludes human readable gradations on an outer portion of the sidewall.In another configuration, the identifiers are part of the human readablegradations. In yet another configuration, the identifiers aretransparent. In one configuration, the identifier is magnetic. Inanother configuration, the sensor is a magnetic sensor. In yet anotherconfiguration, the identifier is IR ink. In one configuration, thesensor is an optical sensor. In another configuration, the identifier isUV ink.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is an assembled, perspective view of a syringe assembly in afirst position with a detection system in accordance with an embodimentof the present invention.

FIG. 2 is an assembled, perspective view of a syringe assembly in afirst position with a detection system in accordance with anotherembodiment of the present invention.

FIG. 3 is an assembled view of a syringe assembly in a second positionwith a detection system in accordance with another embodiment of thepresent invention.

FIG. 4 is an assembled view of a syringe assembly in a second positionwith a detection system in accordance with another embodiment of thepresent invention.

FIG. 5 is an assembled view of a syringe assembly in a second positionwith a detection system in accordance with another embodiment of thepresent invention.

FIG. 6 is an exploded, perspective view of a syringe assembly with adetection system in accordance with another embodiment of the presentinvention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

The present disclosure provides detection systems for a fluid container,such as a syringe assembly, IV bag, pen injector, autoinjector, and thelike that provide precision in monitoring the amount of fluid containedwithin the container, detecting motion of a plunger within thecontainer, and/or monitoring the volume received within or delivered bythe fluid container. In one embodiment, the present disclosure provide adetection system for a syringe barrel, detecting motion of the plungerwithin the syringe barrel, detecting the position of the plunger withinthe syringe barrel, and/or monitoring the volume received within ordelivered by the syringe assembly.

A detection system of the present disclosure allows a sensor incommunication with a portion of a plunger assembly to sense the motionof a plunger rod relative to a syringe barrel and thereby volumereceived within or delivered by the syringe by reading gradations havingan identifier directly as the plunger rod with sensor moves past eachrespective gradation with identifier.

Referring to FIGS. 1-6 , a fluid container, such as a syringe assembly10 having a detection system 18 includes a syringe barrel 12, a plungerrod or plunger assembly 14, and a stopper 16. Syringe assembly 10 may beadapted for dispensing and delivery of a fluid and/or collection of afluid. For example, syringe assembly 10 may be used for injection orinfusion of fluid such as a medication into a patient. Syringe assembly10 is contemplated for use in connection with a needle, such as byconnecting syringe assembly 10 to a separate needle assembly (notshown), or alternatively for connection with an intravenous (IV)connection assembly (not shown). It can be appreciated that the presentdisclosure can be used with any type of syringe assembly. These types ofsyringes include traditional pre-filled syringe assemblies, metered dosesyringes, aspiration syringes for withdrawing fluid from a patient ormedication from a container, and the like. It is also contemplatedherein that the fluid container may also be an IV bag, pen injector,autoinjector, patch-style injector, or the like

Referring to FIGS. 1-6 , syringe barrel 12 generally includes a barrelbody or sidewall 30 extending between a first or distal end 32 and asecond or proximal end 34. The sidewall 30 includes an external surfaceor outer portion 44 and an internal surface or inner portion 46.Proximal end 34 of syringe barrel 12 defines a proximal opening 35 (FIG.6 ). Sidewall 30 defines an elongate aperture or interior chamber 36 ofsyringe barrel 12. In one embodiment, interior chamber 36 may span theextent of syringe barrel 12 so that syringe barrel 12 is cannulatedalong its entire length. In one embodiment, syringe barrel 12 may be inthe general form of an elongated cylindrical barrel as is known in theart in the general shape of a hypodermic syringe. In alternativeembodiments, syringe barrel 12 may be in other forms for containing afluid for delivery, such as in the general form of an elongatedrectangular barrel, for example. Syringe barrel 12 may be formed ofglass, or may be injection molded from thermoplastic material such aspolypropylene and polyethylene according to techniques known to those ofordinary skill in the art, though it is to be appreciated that syringebarrel 12 may be made from other suitable materials and according toother applicable techniques. In certain configurations, syringe barrel12 may include an outwardly extending flange 40 about at least a portionof proximal end 34. Flange 40 may be configured for easy grasping by amedical practitioner.

Distal end 32 of syringe barrel 12 includes an outlet opening 38 whichis in fluid communication with chamber 36. Outlet opening 38 may besized and adapted for engagement with a separate device, such as aneedle assembly or IV connection assembly and, therefore, may include amechanism for such engagement as is conventionally known. For example,distal end 32 may include a generally-tapered luer tip 42 for engagementwith an optional separate tapered luer structure of such a separatedevice for attachment therewith (not shown). In one configuration, boththe tapered luer tip 42 and the separate tapered luer structure may beprovided with syringe assembly 10. In such a configuration, the separatetapered luer structure may be fitted with an attachment mechanism, suchas a threaded engagement, for corresponding engagement with a separatedevice (not shown). In another configuration, tapered luer tip 42 may beprovided for direct engagement with a separate device (not shown). Inaddition, a mechanism for locking engagement therebetween may also beprovided with at least one of tapered luer tip 42 and/or the separatetapered luer structure, such as a luer collar or luer lock includinginterior threads. Such luer connections and luer locking mechanisms arewell known in the art.

Proximal end 34 of syringe barrel 12 is generally open-ended, but isintended to be closed off to the external environment. For example, inone embodiment, the proximal end 34 of syringe barrel 12 defines aproximal opening 35 (FIG. 6 ).

Syringe assembly 10 may be useful as a pre-filled syringe, and,therefore, may be provided for end use with a fluid, such as amedication or drug, contained within interior chamber 36 of syringebarrel 12, pre-filled by the manufacturer. In this manner, syringeassembly 10 can be manufactured, pre-filled with a medication, andsterilized for delivery, storage, and use by the end user, without theneed for the end user to fill the syringe with medication from aseparate vial prior to use. In such an embodiment, syringe assembly 10may include a protective cap disposed over outlet opening 38 at distalend 32 of syringe barrel 12 to seal a fluid F, such as a medication,within interior chamber 36 of syringe barrel 12. The syringe assembly 10may also include additional packaging and sealing portions to enclosethe syringe assembly 10 to seal and protect the fluid F, such as amedication, within interior chamber 36 of syringe barrel 12.

Syringe assembly 10 may also be used to fill syringe barrel 12 with amedication from a separate vial prior to use. For example, syringeassembly 10 may be used with non-preloaded medication kits such as adiabetes therapy kit or other medication kits.

Referring to FIGS. 1-6 , in one embodiment, syringe assembly 10 includesstopper 16 which is moveably or slidably disposed within interiorchamber 36, and in sealing contact with the internal surface of sidewall30 of syringe barrel 12. Stopper 16 is sized relative to the interior ofsyringe barrel 12 to provide sealing engagement with the interiorsurface 46 of sidewall 30 of syringe barrel 12. In a pre-filled syringeassembly, stopper 16 also provides a first seal to prevent liquid ormedication from leaking out of syringe barrel 12. Additionally, in oneembodiment, stopper 16 may include one or more annular ribs 48 extendingaround the periphery of stopper 16 to increase the sealing engagementbetween stopper 16 and the interior surface 46 of sidewall 30 of syringebarrel 12. In alternate embodiments, a singular O-ring or a plurality ofO-rings may be circumferentially disposed about stopper 16 to increasethe sealing engagement with the interior surface of sidewall 30.

Referring to FIGS. 1-6 , syringe assembly 10 further includes plungerrod 14 which provides a mechanism for dispensing fluid contained withininterior chamber 36 of syringe barrel 12 through outlet opening 38.

Plunger rod 14 is adapted for advancing stopper 16. In one embodiment,plunger rod 14 is sized for movement within interior chamber 36 ofsyringe barrel 12 and generally includes a first or distal end 60engageable with a portion of stopper 16, a second or proximal end 62generally opposite first end 60, a plunger rod body 64 extending betweenfirst end 60 and second end 62, and a flange 66 disposed adjacent secondend 62.

Referring to FIGS. 1-6 , in one embodiment, plunger rod 14 includesstabilizing ribs 74 extending between distal end 60 and proximal end 62of plunger rod 14. In one embodiment, stabilizing ribs 74 extend along alongitudinal axis of plunger rod 14. In other embodiments, stabilizingribs 74 may include one or more annular ribs extending around theperiphery of plunger rod 14. Stabilizing ribs 74 provide a means tostabilize plunger rod 14 within syringe barrel 12 and guide plunger rod14 during movement within interior chamber 36 of syringe barrel 12.

Referring to FIGS. 1-6 , plunger rod 14 includes a first end 60 that isengageable with a portion of stopper 16. In one embodiment, plunger rod14 and stopper 16 may include engagement portions for securing plungerrod 14 to stopper 16. For example, the engagement portions may includecorresponding threaded portions for securing plunger rod 14 to stopper16. In other embodiments, the engagement portions may include a snap fitmechanism, a press-fit mechanism, a ball detent, locking tabs, springloaded locking mechanism, latch, adhesive, or other similar mechanism.In another embodiment, plunger rod 14 and stopper 16 may be co-formedsuch as by co-extrusion. Plunger rod 14 is locked to stopper 16, i.e.,significant relative movement between plunger rod 14 and stopper 16 isprevented and movement of plunger rod 14 can be transferred to stopper16 to slide stopper 16 between positions within syringe barrel 12. Inother embodiments, plunger rod 14 and stopper 16 may be integrallyformed as a plunger assembly.

All of the components of syringe assembly 10 may be constructed of anyknown material, and are desirably constructed of medical-grade polymers.

The present disclosure provides detection systems 18 for a syringeassembly 10 that provide precision in monitoring the amount of fluidcontained within the syringe barrel 12, detecting motion of the plunger14 within the syringe barrel 12, detecting the position of the plunger14 within the syringe barrel 12, and/or monitoring the volume receivedwithin or delivered by the syringe assembly 10. Referring to FIGS. 1-6 ,in one embodiment, the detection system 18 of the syringe assembly 10includes an identifier 80 that is part of a first portion of the syringeassembly 10 and a sensor or sensing device 82 that is part of a secondportion of the syringe assembly 10. A detection system 18 of the presentdisclosure allows a sensor 82 in communication with a portion of asyringe assembly 10 and/or plunger assembly 14 to sense the motion of aplunger 14 relative to a syringe barrel 12 and thereby volume receivedwithin or delivered by the syringe 10 by reading gradations 84 having anidentifier 80 directly as the plunger rod 14 with sensor 82 moves pasteach respective gradation 84 with identifier 80.

In one embodiment, syringe barrel 12 include a first set of markings orgradations 84 located on a portion of sidewall 30 of syringe barrel 12for providing an indication as to the level or amount of fluid containedwithin interior chamber 36 of syringe barrel 12 and for providingindications of the additional information described herein. Suchmarkings 84 may be provided on an external surface or outer portion 44of sidewall 30, an internal surface or inner portion 46 of sidewall 30,or integrally formed or otherwise within sidewall 30 of syringe barrel12. In other embodiments, alternatively, or in addition thereto, themarkings 84 may also provide a description of the contents of thesyringe or other identifying information as may be known in the art,such as maximum and/or minimum fill lines.

The plurality of markings or gradations 84 may each include anidentifier 80 that is detectable by a sensor 82. For example, in oneembodiment, the identifier 80 includes gradation markings 84 that areprinted on the syringe barrel 12 using magnetic ink. In such anembodiment, a portion of the syringe assembly 10 or the plunger rod 14includes a sensor 82, e.g., a magnetic sensing sensor, that is able todetect each of the identifiers 80, i.e., the sensor 82 detects themagnetic ink forming the gradation markings 84. In this manner, theidentifier 80 and the sensor 82 form a detection system 18 that providesprecision in monitoring the amount of fluid contained within the syringebarrel, detecting motion of the plunger within the syringe barrel,detecting the position of the plunger within the syringe barrel, and/ormonitoring the volume delivered by the syringe assembly.

Referring to FIG. 1 , in one embodiment, the syringe barrel 12 mayinclude a first identifier 100 including a gradation marking 84 that isprinted on the syringe barrel 12 using magnetic ink, a second identifier102 including a gradation marking 84 that is printed on the syringebarrel 12 using magnetic ink, a third identifier 104 including agradation marking 84 that is printed on the syringe barrel 12 usingmagnetic ink, a fourth identifier 106 including a gradation marking 84that is printed on the syringe barrel 12 using magnetic ink, a fifthidentifier 108 including a gradation marking 84 that is printed on thesyringe barrel 12 using magnetic ink, and a sixth identifier 110including a gradation marking 84 that is printed on the syringe barrel12 using magnetic ink. In some embodiments, additional identifiers 80including a gradation marking 84 that is printed on the syringe barrel12 using magnetic ink may be included on the syringe barrel 12 for aparticular application. In other embodiments, less identifiers 80including a gradation marking 84 that is printed on the syringe barrel12 using magnetic ink may be included on the syringe barrel 12 for otherapplications. It is envisioned that a detection system 18 of the presentdisclosure can be adapted to include any number of identifiers 80 in anyparticular patterns for a variety of different applications.

In this manner, as the plunger rod 14 moves from a fully retractedposition, as shown in FIG. 3 , toward the distal end 32 of syringebarrel 12 in a direction generally along arrow B (FIG. 3 ), the sensor82 is able to determine movement along the syringe barrel 12 bydetecting the printed pattern of the magnetic ink in the identifiers100, 102, 104, 106, 108, 110. Furthermore, in this manner, the detectionsystem 18 of the present disclosure also provides precision inmonitoring the amount of fluid contained within the syringe barrel,detecting motion of the plunger within the syringe barrel, detecting theposition of the plunger within the syringe barrel, and/or monitoring thevolume delivered by the syringe assembly.

In other words, the detection system 18 of the present disclosure allowsa sensor 82 in communication with a portion of the syringe assembly 10or the plunger rod 14 to sense the motion of the plunger rod 14 relativeto the syringe barrel 12 and thereby volume received within or deliveredby the syringe 10 by reading the gradations 84 having an identifier 80directly as the plunger rod 14 with sensor 82 moves past each respectivegradation 84 with identifier 80.

Referring to FIG. 1 , in one embodiment, the line weight of each of theidentifiers 100, 102, 104, 106, 108, 110 is varied so that the strengthof the signal detected by the sensor 82 provides information about theabsolute position of the plunger rod 14 relative to the syringe barrel12.

As described above, in one embodiment, the detection system 18 of thepresent disclosure includes a magnetic sensor 82 paired with magneticink identifiers 80. In other embodiments, the detection system 18 of thepresent disclosure may include other pairings of a sensor 82 with anidentifier 80.

For example, referring to FIG. 2 , in another embodiment, the identifier80 includes gradation markings 84 that are printed on the syringe barrel12 using UV reflective ink. In such an embodiment, a portion of thesyringe assembly 10 or the plunger rod 14 includes a sensor 82 that isable to detect each of the identifiers 80, i.e., the sensor 82 detectsthe UV reflective ink forming the gradation markings 84. In this manner,the identifier 80 and the sensor 82 form a detection system 18 thatprovides precision in monitoring the amount of fluid contained withinthe syringe barrel, detecting motion of the plunger within the syringebarrel, detecting the position of the plunger within the syringe barrel,and/or monitoring the volume delivered by the syringe assembly. In suchan embodiment, the sensor 82 is able to more readily read information onthe syringe gradations by enhanced signals that are provided to thesensor 82 by the UV reflective ink. In such an embodiment, a UV or othernon-visible optically active ink could be used to enhance thefunctionality of the sensor 82 and signals generated. It is alsocontemplated herein that the identifier 80 could also include otherinformation which would otherwise be printed on a label applied to thedevice, such as, the kind of fluid container and/or contents of thefluid container. By including this kind of information within theidentifier 80, information which would otherwise be printed on a labelfoes not inhibit or block a user's normal use of the syringe's visiblegradations, contents or volume.

In another embodiment, the identifier 80 includes gradation markings 84that are printed on the syringe barrel 12 using IR ink. In such anembodiment, a portion of the plunger rod 14 includes a sensor 82, e.g.,an optical sensor, that is able to detect each of the identifiers 80,i.e., the sensor 82 detects the IR ink forming the gradation markings84. In this manner, the identifier 80 and the sensor 82 form a detectionsystem 18 that provides precision in monitoring the amount of fluidcontained within the syringe barrel, detecting motion of the plungerwithin the syringe barrel, detecting the position of the plunger withinthe syringe barrel, and/or monitoring the volume delivered by thesyringe assembly.

Referring to FIGS. 4 and 5 , in some embodiments, the sensor 82 ispositioned within a portion of the plunger rod 14, or stopper 16, todetect the identifiers 80 forming the gradation markings 84 anddetermine the position of the plunger rod 14 based on this detection. Inother embodiments, the sensor 82 may be in communication with otherportions of the plunger rod 14 and/or the stopper 16. For example, inother embodiments, it is envisioned that the sensor 82 is mounted on aportion of the plunger rod 14, the sensor 82 is formed as part of aportion of the plunger rod 14, the sensor 82 is positioned within aportion of the stopper 16, the sensor 82 is mounted on a portion of thestopper 16, or the sensor 82 is formed as part of a portion of thestopper 16. For example, referring to FIGS. 2 and 3 , in someembodiments, the sensor or sensing device 82 may be in communicationwith a portion of the plunger assembly 14 and disposed outside of thesyringe barrel 12. In some embodiments, referring to FIG. 6 , the sensor82 may be part of the stopper 16.

In one embodiment, the syringe barrel 12 may include a first set ofmarkings or gradations 84 that have the identifiers 80 therein and asecond set of markings or gradations 86 that have human readablegradations.

For example, referring to FIG. 5 , in one exemplary embodiment, thefirst set of markings or gradations 84 that have the identifiers 80 arelocated on an inner portion 46 of the sidewall 30 of the syringe barrel12 and the second set of markings or gradations 86 that have humanreadable gradations are located on an outer portion 44 of the sidewall30 of the syringe barrel 12. In this manner, the detection system 18 ofthe present disclosure prints the identifiers 80 on an opposing side ofthe syringe barrel 12, e.g., the inner portion 46, from the humanreadable gradations 86 that are located on the outer portion 44. Such aconfiguration keeps the outer portion 44 of the syringe barrel 12 freefor user observation while utilizing the inner portion 46 of the syringebarrel 12 for detection and sensing capabilities. This configurationalso provides the added benefit of the human readable gradations 86,located on the outer portion 44 of the syringe barrel 12, beingaccessible by normally intended line of sight. Furthermore, in oneembodiment, the identifiers 80 on a portion of the syringe barrel 12 aretransparent to prevent confusion to a user while reading the humanreadable gradations 86.

Referring to FIGS. 3 and 4 , in another exemplary embodiment, the firstset of markings or gradations 84 that have the identifiers 80 arelocated on an outer portion 44 of the sidewall 30 of the syringe barrel12 and the second set of markings or gradations 86 that have humanreadable gradations are located on an outer portion 44 of the sidewall30 of the syringe barrel 12. In one such embodiment, the identifiers 80may be part of the human readable gradations 86. For example, theidentifiers 80 may be added to a portion of each of the human readablegradations 86. In another such embodiment, the identifiers 80 may beseparate from the human readable gradations 86.

As described above, in some embodiments, plunger rod 14 and stopper 16may be integrally formed as a plunger assembly. The integrally formedplunger assembly 14 includes the first end 60, the second end 62, and aplunger stopper portion, e.g., a stopper 16 that is integrally formedwith a plunger rod 14, which is slidably disposed within the interior 36of the syringe barrel 12. The plunger stopper portion is sized relativeto the interior 36 of the syringe barrel 12 to provide sealingengagement with the sidewall 30 of the syringe barrel 12. In suchembodiments, a sensor 82 of the detection system 18 of the presentdisclosure is in communication with a portion of the plunger assembly14. For example, it is envisioned that the sensor 82 is positionedwithin a portion of the plunger assembly 14, the sensor 82 is mounted ona portion of the plunger assembly 14, or the sensor 82 is formed as partof a portion of the plunger assembly 14. Referring to FIGS. 2 and 3 , insome embodiments, the sensor or sensing device 82 may be incommunication with a portion of the plunger assembly 14 and disposedoutside of the syringe barrel 12. In such embodiments, a variety ofdifferent configurations of the detection system 18 of the presentdisclosure are envisioned as described in detail above.

Referring now to FIGS. 1-6 , the use of syringe assembly 10 withdetection system 18 of the present disclosure to fill syringe barrel 12with medication from a separate vial prior to use will now be described.With syringe assembly 10 in the position shown in FIGS. 1 and 2 and witha needle assembly locked to distal end 32 of syringe barrel 12 andplaced in communication with a vial containing fluid, when it is desiredto aspirate or pull the fluid, such as a medication, into chamber 36 ofsyringe barrel 12, a user moves plunger rod 14 in a direction generallyalong arrow A (FIG. 2 ) until the desired amount of the fluid is pulledinto chamber 36 of syringe barrel 12. In this manner, movement ofstopper 16 via plunger rod 14 in the direction generally along arrow A(FIG. 2 ) creates a vacuum inside chamber 36 of syringe barrel 12. Asthe user moves stopper 16 via plunger rod 14 from the position shown inFIG. 2 towards the position shown in FIG. 3 , the user activelyincreases the volume within chamber 36 of syringe barrel 12. Because thestopper 16 is sized relative to syringe barrel 12 to provide sealingengagement with the interior wall 46 of syringe barrel 12, as describedabove, and because the needle assembly locked to distal end 32 ofsyringe barrel 12 is placed in a vial containing fluid, no air can enterinto chamber 36 of syringe barrel 12 and, thus, the same number of airmolecules are located within chamber 36 as the user actively increasesthe volume within chamber 36. This decreases the pressure in chamber 36of syringe barrel 12 relative to the air pressure outside of syringebarrel 12. Therefore, a vacuum, i.e., a space of lower air pressure, iscreated to pull the fluid, such as a medication, into chamber 36 ofsyringe barrel 12.

The detection system 18 of the present disclosure allows a sensor 82 incommunication with a portion of the syringe assembly 10 or the plungerrod 14 to sense the motion of the plunger rod 14 relative to the syringebarrel 12 as a user moves plunger rod 14 in a direction generally alongarrow A (FIG. 2 ) until the desired amount of the fluid is pulled intochamber 36 of syringe barrel 12 by reading the gradations 84 having anidentifier 80 directly as the plunger rod 14 with sensor 82 moves pasteach respective gradation 84 with identifier 80. In this manner, thedetection system 18 of the present disclosure provides precision inmonitoring the amount of fluid contained within the syringe barrel,detecting motion of the plunger within the syringe barrel, and/ordetecting the position of the plunger within the syringe barrel.

The syringe assembly 10 with detection system 18 of the presentdisclosure may also be used in a pre-filled syringe assembly and/or aninjectable syringe assembly. In this manner, the need for the user tofill the device prior to injection is eliminated, thereby saving timeand maintaining consistent volumes for delivery.

Referring to FIG. 3 , the use of syringe assembly 10 with detectionsystem 18 of the present disclosure to expel a fluid, such as amedication, contained within chamber 36 of syringe barrel 12 will now bedescribed. Referring to FIG. 3 , a fluid F is contained within chamber36 of syringe barrel 12. In one embodiment, fluid F is contained withinchamber 36 between stopper 16 and distal end 32 of syringe barrel 12. Auser can then attach tip 42 of syringe barrel 12 to a separate needleassembly or IV connection assembly and lockingly engage the needleassembly or IV connection assembly to tip 42 of syringe barrel 12 in aknown manner. Prior to dispensing any medication, any air trapped withinchamber 36 of syringe barrel 12 can be expelled in a known manner.

When it is desired to expel or deliver the medication contained withinsyringe barrel 12, syringe assembly 10 is grasped with the user's thumbon flange 66 of plunger rod 14 and with the user's fingers extendingaround flange 40 of syringe barrel 12. In this manner, syringe assembly10 is grasped by a user in a well-known and well recognized manner.Next, the user effects a squeezing movement between the thumb on flange66 of plunger rod 14 and four fingers grasping flange 40 of syringebarrel 12, thereby causing stopper 16 via plunger rod 14 to move in adirection generally along arrow B (FIG. 3 ). In this manner, movement ofstopper 16 via plunger rod 14 in the direction generally along arrow Bforces the fluid F contained within chamber 36 of syringe barrel 12 tobe forced out outlet opening 38. The fluid can be expelled from syringebarrel 12 through outlet opening 38 into a separate needle assembly orIV assembly and into the patient.

Advantageously, using the detection system 18 of the present disclosure,as the plunger rod 14 moves from a fully retracted position, as shown inFIG. 3 , toward the distal end 32 of syringe barrel 12 in a directiongenerally along arrow B (FIG. 3 ), the sensor 82 is able to determinemovement along the syringe barrel by detecting the printed pattern ofthe magnetic ink in the identifiers 100, 102, 104, 106, 108, 110 (FIG. 1). Furthermore, in this manner, the detection system 18 of the presentdisclosure also provides precision in monitoring the amount of fluidcontained within the syringe barrel, detecting motion of the plungerwithin the syringe barrel, detecting the position of the plunger withinthe syringe barrel, and/or monitoring the volume delivered by thesyringe assembly.

In other words, the detection system 18 of the present disclosure allowsa sensor 82 in communication with a portion of the plunger rod 14 tosense the motion of the plunger rod 14 relative to the syringe barrel 12and thereby volume delivered by the syringe 10 by reading the gradations84 having an identifier 80 directly as the plunger rod 14 with sensor 82moves past each respective gradation 84 with identifier 80.

In one exemplary embodiment, the detection systems of the presentdisclosure integrates the addition of an additive that functions as anidentifier to a human readable ink on a portion of a syringe barrel toprovide precision in monitoring the amount of fluid contained within thesyringe barrel, detecting motion of the plunger within the syringebarrel, detecting the position of the plunger within the syringe barrel,and/or monitoring the volume received within or delivered by the syringeassembly. In another exemplary embodiment, the detection systems of thepresent disclosure introduce an additive that functions as an identifierto an opposite side of a syringe barrel from a human readable ink tokeep an outer portion with the human readable ink free for observationwhile utilizing an inner portion with the identifier for detection andsensing capabilities.

Furthermore, the application of the detection system and syringeidentification by the detection of gradations of the present disclosurecan include mechanical advantages to external operations and functionsthrough co-operating devices. Ink additives can act as a signature to amethod of detection for mechanical specific adaptation. Ink additivescan also act as an assisting mechanism for sensing administration as astopper of a plunger assembly creates a greater contrast as the stopperand/or plunger assembly moves past each respective gradations withidentifier. Ink additives can also include sensing-assistive propertiesto improve functions including the following: (1) optical, e.g., opticalarray, optical scanner or linear scanner, sparsely populated array withpattern matching; (2) RF based antenna; (3) IR/Ultrasonic TOF; (4)inductive encoder or LVDT; (5) interferometry; (6) magnetic encoder,digital image correlation or darkfield laser tracking, as in an opticalmouse; (7) capacitive; or (8) resistance based. Additionally, use offunctional ink allows for the printing of a pattern on a syringe thatprovides a means of absolute position sensing via having a uniquepattern or distance between the markings of the ink to allow for aspecific variation on the signal received by the sensor.

The addition of magnetic particles to syringe gradations, or otheroptical elements, creates a greater contrast between the plunger rod andthe syringe gradients for enhanced viewing by a sensor. Additionally,the addition of magnetic particles to syringe gradations, or otheroptical elements, aids a sensor mounted on the plunger rod itself tosense the motion of the plunger rod and thereby the volume delivered bythe syringe by reading the syringe markings directly as it moves pastthem. A sensor of the detection system may also be manufactured as partof a plunger assembly, e.g., as an addition or modification to thestopper. The sensor type and markings could be of any of a number ofdifferent technologies.

Additional applications of the inks and detection systems of the presentdisclosure may be utilized in other means of fluid transfer in a medicalenvironment. The inks could be added to other medical containers such aspen injectors or IV bags for tracking consumption. It could also beapplied in diagnostic applications for sample tracking and processing,and in robotic applications of filling or transferring fluids such asdrug compounding.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A medical device, comprising: a first tubularmember defining an interior; a second tubular member having a first end,a second end, and a sidewall extending therebetween, at least a portionof the second tubular member configured to be slidably disposed withinthe interior of the first tubular member; a plurality of gradationslocated on a portion of the sidewall of the second tubular member, eachof the plurality of gradations including an identifier; and a sensor incommunication with a portion of the second tubular member, wherein thesensor detects the identifier.
 2. The medical device of claim 1, whereinthe first tubular member is a tube having a lumen and the second tubularmember is a catheter.
 3. The medical device of claim 1, wherein thesensor is positioned within a portion of the first tubular member. 4.The medical device of claim 1, wherein the sensor is mounted on aportion of the first tubular member.
 5. The medical device of claim 1,wherein the sensor is formed as part of a portion of the first tubularmember.
 6. The medical device of claim 1, wherein the gradations arelocated on an inner portion of the sidewall.
 7. The medical device ofclaim 6, further comprising human readable gradations on an outerportion of the sidewall.
 8. The medical device of claim 1, wherein thegradations are located on an outer portion of the sidewall.
 9. Themedical device of claim 8, further comprising human readable gradationson an outer portion of the sidewall.
 10. The medical device of claim 9,wherein the identifiers are part of the human readable gradations. 11.The medical device of claim 1, wherein the identifiers are transparent.12. The medical device of claim 1, wherein the identifier is magnetic,and the sensor is a magnetic sensor.
 13. The medical device of claim 1,wherein the identifier is IR ink.
 14. The medical device of claim 13,wherein the sensor is an optical sensor.
 15. The medical device of claim1, wherein the identifier is UV ink.
 16. A catheter assembly,comprising: a tube defining a lumen; a catheter having a first end, asecond end, and a sidewall extending therebetween, at least a portion ofthe catheter configured to be slidably disposed within the lumen of thetube; a plurality of gradations located on a portion of the sidewall ofthe catheter, each of the plurality of gradations including anidentifier; and a sensor that detects the identifier.
 17. The catheterassembly of claim 16, wherein the sensor is positioned within a portionof the tube.
 18. The catheter assembly of claim 16, wherein the sensoris mounted on a portion of the tube.
 19. The catheter assembly of claim16, wherein the sensor is formed as part of a portion of the tube. 20.The catheter assembly of claim 16, wherein the gradations are located onan inner portion of the sidewall.
 21. The catheter assembly of claim 16,wherein the gradations are located on an outer portion of the sidewall.22. The catheter assembly of claim 16, wherein the identifiers aretransparent.
 23. The catheter assembly of claim 16, wherein theidentifiers are magnetic, and wherein the sensor is a magnetic sensor.24. The catheter assembly of claim 16, wherein the identifier is IR ink.25. The catheter assembly of claim 16, wherein the sensor is an opticalsensor.
 26. The catheter assembly of claim 16, wherein the identifier isUV ink.
 27. The medical device of claim 1, further comprising: a markerlocated adjacent to a point of entry of at least one of the firsttubular member and the second tubular member into a patient.
 28. Themedical device of claim 27, wherein the marker is magnetic, and thesensor is a magnetic sensor.
 29. The medical device of claim 27, whereinthe marker is IR ink.
 30. The medical device of claim 29, wherein thesensor is an optical sensor.
 31. The medical device of claim 27, whereinthe marker is UV ink.
 32. The catheter assembly of claim 16, furthercomprising: a marker located adjacent to a point of entry of at leastone of the tube and the catheter into a patient.
 33. The catheterassembly of claim 32, wherein the marker is magnetic, and wherein thesensor is a magnetic sensor.
 34. The catheter assembly of claim 32,wherein the marker is IR ink.
 35. The catheter assembly of claim 34,wherein the sensor is an optical sensor.
 36. The catheter assembly ofclaim 32, wherein the marker is UV ink.